Genzyme Ireland Limited
FDA inspection history in Waterford, Ireland, 2017 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2017: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Waterford, Ireland.
- 2025–26One Form 483 and one warning letter, at Waterford, Ireland.
- 2025The longest 483 on file: 4 observations over 3 pages at Waterford, Ireland.
Cited most
Across all Genzyme Ireland Limited observations on file
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
The complete Genzyme Ireland Limited file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Waterford, Ireland
Two Form 483s and one warning letter · 2017 to 2026 · 8 observations
Latest: Warning letter, Jun 22, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-06-22 | Warning letter Warning letter | Waterford, Ireland | — | $99 |
| 2025-01-17 | 483 Form 483 | Waterford, Ireland | 4 | $99 |
| 2017-09-01 | 483 Form 483 | Waterford, Ireland | 4 | $99 |
Investigators on these documents
FEI number 3003809840 · most recent document Jun 22, 2026
About Genzyme Ireland Limited
How many FDA Form 483s has Genzyme Ireland Limited received?
FDA Intel has 2 Form 483s on file for Genzyme Ireland Limited; the most recent is dated Jan 17, 2025.
When was Genzyme Ireland Limited last inspected by FDA?
The most recent FDA inspection document on file for Genzyme Ireland Limited is a Form 483 dated Jan 17, 2025, for the site in Waterford, Ireland.
What did FDA cite at Genzyme Ireland Limited?
The regulations cited most in the observations on file for Genzyme Ireland Limited are 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.
Has Genzyme Ireland Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Genzyme Ireland Limited; the most recent is dated Jun 22, 2026.